Abstract
Background: Given that pregnant women are now included among those for receipt coronavirus disease 2019 (COVID-19) vaccines, it is important to ensure that information systems can be used (or available) for active safety surveillance, especially in low- and middle-income countries (LMICs). The aim of this study was to build consensus about the use of existing maternal and neonatal data collection systems in LMICs for COVID-19 vaccines active safety surveillance, a basic set of variables, and the suitability and feasibility of including pregnant women and LMIC research networks in COVID-19 vaccines pre-licensure activities. Methods: A three-stage modified Delphi study was conducted over three months in 2020. An international multidisciplinary panel of 16 experts participated. Ratings distributions and consensus were assessed, and ratings' rationale was analyzed. Results: The panel recommended using maternal and neonatal data collection systems for active safety surveillance in LMICs (median 9; disagreement index [DI] -0.92), but there was no consensus (median 6; DI 1.79) on the feasibility of adapting these systems. A basic set of 14 maternal, neonatal, and vaccination-related variables. Out of 16 experts, 11 supported a basic set of 14 maternal, neonatal, and vaccination-related variables for active safety surveillance. Seven experts agreed on a broader set of 26 variables. The inclusion of pregnant women for COVID-19 vaccines research (median 8; DI -0.61) was found appropriate, although there was uncertainty on its feasibility in terms of decision-makers' acceptability (median 7; DI 10.00) and regulatory requirements (median 6; DI 0.51). There was no consensus (median 6; DI 2.35) on the feasibility of including research networks in LMICs for conducting clinical trials amongst pregnant women. Conclusions: Although there was some uncertainty regarding feasibility, experts recommended using maternal and neonatal data collection systems and agreed on a common set of variables for COVID-19 vaccines active safety surveillance in LMICs.
Highlights
The coronavirus disease 2019 (COVID-19) pandemic has created unprecedented global health challenges, triggering an accelerated development and distribution of safe and effective vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)[1]
The World Health Organization (WHO) interim guidance for COVID-19 vaccines has recommended that pregnant women should be vaccinated against COVID-19 on the basis of a benefit vs risk assessment[4,5]
Limited data from clinical trials is available on COVID-19 vaccine safety, immunogenicity, reactogenicity, and efficacy in pregnancy and their potential effects on the fetus or the neonate, in LMICs4–6
Summary
The coronavirus disease 2019 (COVID-19) pandemic has created unprecedented global health challenges, triggering an accelerated development and distribution of safe and effective vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)[1]. The aim of this study was to build consensus about the use of existing maternal and neonatal data collection systems in LMICs for COVID-19 vaccines active safety surveillance, a basic set of variables, and the suitability and feasibility of including pregnant women and LMIC research networks in COVID19 vaccines pre-licensure activities. Results: The panel recommended using maternal and neonatal data collection systems for active safety surveillance in LMICs (median 9; disagreement index [DI] -0.92), but there was no consensus (median 6; DI 1.79) on the feasibility of adapting these systems. Conclusions: there was some uncertainty regarding feasibility, experts recommended using maternal and neonatal data collection systems and agreed on a common set of variables for COVID-19 vaccines active safety surveillance in LMICs
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